This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00151047
First received: September 6, 2005
Last updated: January 19, 2015
Last verified: January 2015
  Purpose
Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to determine if this treatment is an acceptable, effective and a safe treatment option. In addition, this clinical trial will evaluate how this treatment affects chemicals (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical trial will conduct extra imaging studies for research purposes including combined endorectal prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.

Condition Intervention Phase
Prostate Cancer Drug: Capecitabine Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Primary Chemotherapy With Docetaxel Plus Capecitabine in Selected Patients With Newly Diagnosed Localized or Locally Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • The percentage of patients who respond to treatment [ Time Frame: 6 months ]
    To evaluate the response rate associated with capecitabine and docetaxel combination chemotherapy in selected patients with localized or locally advanced prostate cancer. Response is defined as a reduction in the PSA (Prostate Specific Antigen) by at least 50%.


Enrollment: 15
Study Start Date: March 2003
Study Completion Date: October 2007
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel and Capecitabine Drug: Capecitabine Drug: Docetaxel

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients must have newly diagnosed prostate cancer with at least one of the following criteria:

  • Clinical Stage > T2
  • PSA > 15 ng/ml
  • Biopsy Gleason's sum > 8
  • All patients must have a minimum PSA value of > 5 ng/ml.
  • Patients may not have evidence of distant systemic metastasis.
  • Patients may not undergo concurrent hormonal, biologic, or chemotherapy.
  • Patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
  • Patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible.
  • Patients may not have an underlying cardiac disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151047

Locations
United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Maha Hussain, MD The University of Michigan Comprehensive Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00151047     History of Changes
Other Study ID Numbers: UMCC 2-42
Study First Received: September 6, 2005
Last Updated: January 19, 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2017